UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053077 |
|---|---|
| Receipt number | R000060278 |
| Scientific Title | Study of Autoimmunity and Inflammation in Ocular Diseases |
| Date of disclosure of the study information | 2023/12/12 |
| Last modified on | 2023/12/12 18:50:43 |
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Basic information
Public title
Study of Autoimmunity and Inflammation in Ocular Diseases
Acronym
Autoimmunity and Inflammation in Ocular Diseases
Scientific Title
Study of Autoimmunity and Inflammation in Ocular Diseases
Scientific Title:Acronym
Autoimmunity and Inflammation in Ocular Diseases
Region
| Japan |
Condition
Condition
Eye diseases such as glaucoma and retinitis pigmentosa
Classification by specialty
| Ophthalmology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the relationship between the gut microbiota and auto-retinal antibodies in patients and healthy individuals, and the onset, progression, and severity of eye diseases, aiming to elucidate their impact on ocular conditions.
Basic objectives2
Others
Basic objectives -Others
By elucidating the relationship between the status of the gut microbiota, auto-retinal antibodies, and eye diseases, there is potential for the development of novel therapeutic approaches that involve modifying the gut microbiota and suppressing disease progression through the inhibition of inflammation by auto-retinal antibodies. This could have significant medical implications.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual field test
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | months-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with ocular diseases where autoimmune or inflammatory mechanisms are considered, who visited the Department of Ophthalmology, Kyoto University Hospital, and normal volunteers.
Key exclusion criteria
Patients who have received systemic administration of antibiotics, antiviral drugs, immunosuppressants, or steroids within one month prior to fecal sample collection for gut microbiota analysis.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hanako |
| Middle name | |
| Last name | Ikeda |
Organization
Kyoto University Hospital
Division name
Ohpthalmology
Zip code
6068507
Address
Shogoin-kawahara-cho. Sakyo-ku, Kyoto
TEL
0757513248
hanakoi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hanako |
| Middle name | Ohashi |
| Last name | Ikeda |
Organization
Kyoto University Hospital
Division name
Ophthalmology
Zip code
6068507
Address
Shogoin-kawahara-cho, Sakyo, Kyoto
TEL
0757513248
Homepage URL
hanakoi@mbox.kyoto-inet.or.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate school and faculty of medicine, Ethics committee
Address
Yoshida-konoe, Sakyo, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Using nucleic acids extracted from the feces of study participants for the analysis of gut microbiota. Analyzing the presence, types, and quantities of autoantibodies in the serum of study participants.
Management information
Registered date
| 2023 | Year | 12 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060278
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
